Document Control Manager – Pharma QMS/eDMS Lead

Celcuity Inc.; United States; Sur place; USD 100 000 - 120 000; Plein temps

Avantages offerts par ce poste

Medical, dental, vision insurance

401(k) match

PTO and paid holidays

Résumé du poste

Celcuity Inc. seeks a document control professional to oversee controlled documents in the eDMS, manage change workflows, and migrate legacy files into the eQMS. The role collaborates with Training Admin to ensure accurate training materials and SOPs are current.

Requirements include a life sciences degree (or relevant experience), 5+ years in pharma document control, and familiarity with FDA 21 CFR Part 11, ISO 9001, GMP. Strong communication and attention to detail are essential.

Qualifications

• Bachelor’s degree in the life sciences, chemistry, or related field; or relevant experience.
• 5+ years of document control experience in a pharmaceutical company or related area.
• Experience with electronic document management systems; Veeva strongly preferred.
• Knowledge of version control practices and document lifecycle workflows.
• Familiarity with FDA 21 CFR Part 11, ISO 9001, GMP.
• Strong formatting, metadata tagging and ability to create/correct Word styles.
• Auditing and compliance tracking capabilities.
• Excellent written and verbal communication; ability to influence at all levels.
• Strong interpersonal skills and ability to manage multiple documentation requirements.

Responsabilités

• Facilitates creation, revision, and retirement of controlled documents in the eDMS and manages change control workflows.
• Manages and migrates legacy files into the eQMS.
• Coordinates with Training Admin to create or revise training related to controlled documents.
• Assists eDMS users with document creation/revision and updates SOPs and work instructions.
• Helps users locate current effective documents.
• Facilitates meetings with QMS Admin and document reviewers to complete content creation or revisions.
• Manages GxP record retention and destruction tasks.
• Facilitates Certified Copy creation and retention.
• Other duties as assigned.

Connaissances

Attention to detail

Documentation expertise

Communication

Decision-making

Continuous improvement mindset

Formation

Bachelor’s degree in life sciences or related field

Outils

Veeva

MS Office (Word, Excel, PowerPoint)

Description du poste

Celcuity Inc. seeks a document control professional to oversee controlled documents in the eDMS, manage change workflows, and migrate legacy files into the eQMS. The role collaborates with Training Admin to ensure accurate training materials and SOPs are current.

Requirements include a life sciences degree (or relevant experience), 5+ years in pharma document control, and familiarity with FDA 21 CFR Part 11, ISO 9001, GMP. Strong communication and attention to detail are essential.